DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant's election with traverse of Group III, claims 18-30, in the reply filed on 23 December 2025 is acknowledged. The traversal is on the ground(s) that “the Office has not shown that the methods of Claims 31-36 (i.e., Group I) can be practiced by a materially different apparatus.” Without agreeing or disagreeing, Applicant has amended the claims to have the claims of Group I (claims 31-36) be dependent to claim 19.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 18 and 31 are objected to because of the following informalities:
“wherein the wearable” in line 6 of claim 18 should read as “wherein the plurality of wearable”
“breadth” in line 9 of claim 31 should read as “breath”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18, 21, and 31 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 19, 20, 22-30 and 32-36 are further rejected due to their dependency to claim 18 or 31.
Regarding claims 18 and 31, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “optimal” in claim 28 is a relative term which renders the claim indefinite. The term “optimal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what it means for a breathing strategy to be “optimal.” [0019] of the PGPUB mentions the gold standers for breathing for runners and swimmers. However, [0019] also states that “there is no proof that this is the optimal for all users.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18-36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 18 follows.
STEP 1
Regarding claim 18, the claim recites a series of structural elements, including a controller. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
a controller for calculating a metabolic rate of a user;
wherein the gas exchange analyzer is configured to calibrate a respiratory-system mathematical model of the user during a calibration phase;
a monitoring device communicating with the controller over a network;
the controller calculates the metabolic rate of the user during the use phase by applying the blood oxygen concentration and the lung concentration to the respiratory-system mathematical model
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 18 recites the controller calculates the metabolic rate of the user during the use phase by applying the blood oxygen concentration and the lung concentration to the respiratory-system mathematical model, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The calculating of the metabolic rate by applying the blood oxygen concentration and the lung oxygen concentration to the respiratory-system mathematical model does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the calculated metabolic rate, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional step of: wherein the plurality of wearable sensors are configured to measure a blood oxygen concentration of the user, and the lung oxygen concentration of the user, during a use phase. The measuring step is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the measuring step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining step does not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 18, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited plurality of wearable sensors are generic sensors configured to perform pre-solutional data gathering activity, the monitoring device is configured to perform insignificant extra-solution activity, and the controller and gas exchange analyzer are configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims. Claims 19, 20, 22, 23, 25, 29, 30, and 33 recite what each sensor is, which does not add anything significantly more. Claims 21, 24, 26-28, 32, and 34-36 recite steps that add to the Abstract Idea as each claim recites steps that can be performed mentally or by hand. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18-21, 23-27, 29-34, and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ross et al. ‘390 (US Pub No. 2004/0186390).
Regarding claim 18, Ross et al. ‘390 teaches a system (Title, Abstract), comprising:
a controller (Fig. 1E computation module 52 and [0050]) for calculating a metabolic rate of the user (Abstract);
a gas exchange analyzer (Fig. 1A respiratory analyzer and [0038]) couplable to the controller ([0051]; “The flow module…transmit[s] data to a computation module 88[/86].”), wherein the gas exchange analyzer is configured to calibrate a respiratory-system mathematical model of the user during a calibration phase ([0136]);
a plurality of wearable sensors coupled to the controller (Fig. 1E/1F flow analyzer/module 50/72, gas component sensor 74, physiological sensor 58, activity sensor 60 and [0050]-[0051], [0169]; “oximeter”), wherein the wearable sensors are configured to measure a blood oxygen concentration of the user ([0179]; “…a computation module…receives data corresponding to arterial hemoglobin oxygen saturation, for example from a pulse oximeter.”), and lung oxygen concentration of the user ([0123]; “inhaled and exhaled oxygen volumes”), during a use phase; and
a monitoring device communicating with the controller over a network (Fig. 1E communications network 54 and [0050], [0146]), wherein:
the controller calculates the metabolic rate of the user during the use phase by applying the blood oxygen concentration and the lung oxygen concentration to the respiratory-system mathematical model ([0179]-[0186]; “…a computation module receives data from a flow module so as to determine oxygen consumption (VO2)…and further receives data corresponding to arterial hemoglobin oxygen saturation…the computation module may then be adapted to determine cardiac output, as well as metabolic rate.”); and
the gas exchange analyzer is optionally wearable by the user during the use phase (Figs. 1A, 1B and [0038], [0047]).
Regarding claim 19, Ross et al. ‘390 teaches wherein the plurality of wearable sensors comprise an oxygen saturation sensor ([0179]), a lung oxygen concentration sensor, ([0043]) a breathing rate sensor ([0042]), a heart rate sensor ([0143]), or any combination thereof.
Regarding claim 20, Ross et al. ‘390 teaches wherein the controller is a wearable device ([0143]).
Regarding claim 21, Ross et al. ‘390 teaches wherein the system further comprises at least one environmental sensor configured to measure atmospheric temperature, pressure, humidity, oxygen concentration, or any combination thereof ([0193]).
Regarding claim 23, Ross et al. ‘390 teaches wherein the at least one environmental sensor includes a non-wearable environmental sensor that obtains environmental data over the network ([0193]; “cycle”).
Regarding claim 24, Ross et al. ‘390 teaches a timer for generating a measurement time stamp (Fig. 1F clock 82 and [0051]).
Regarding claim 25, Ross et al. ‘390 teaches wherein the oxygen saturation sensor comprises an arterial oxygen saturation (SpO2) sensor ([0179]).
Regarding claim 26, Ross et al. ‘390 teaches wherein the lung oxygen concentration is calculated from the at least one environmental sensor ([0193]) and a breathing rate sensor ([0171]).
Regarding claim 27, Ross et al. ‘390 teaches wherein the calibration phase may include a recalibration phase in which the gas exchange analyzer is used to recalibrate the respiratory-system mathematical model due to lung performance of the user changing over time ([0210]; “Using a predetermined calibration function between heart rate and other physiological parameter (such as metabolic rate, respiratory quotient, fat burning rate, and the like)…”).
Regarding claim 29, Ross et al. ‘390 teaches wherein the monitoring device comprise a smartphone, a smartwatch, a laptop computer, a server, or any combination thereof ([0141]-[0144]).
Regarding claim 30, Ross et al. ‘390 teaches wherein the oxygen saturation sensor comprises a pulse oximetry sensor ([0179]).
Regarding claim 31, Ross et al. ‘390 teaches a method for determining the metabolic rate of a user with the system of claim 19, the method comprising:
optionally calibrating the respiratory-system mathematical model of the user with the gas exchange analyzer ([0136], [0210]);
measuring breath rate of the user with the breathing rate sensor ([0042]);
measuring heart rate of the user with the heart rate sensor ([0143]);
measuring oxygen saturation in the blood of the user with the oxygen saturation sensor ([0179]);
measuring lung oxygen concentration in the lungs of the user ([0043]);
calculating the metabolic rate of the user from the breadth rate, the heart rate, the oxygen saturation and the lung oxygen concentration of the user based on the respiratory-system mathematical model ([0179]-[0186]; “…a computation module receives data from a flow module so as to determine oxygen consumption (VO2)…and further receives data corresponding to arterial hemoglobin oxygen saturation…the computation module may then be adapted to determine cardiac output, as well as metabolic rate.” [0123], [0206]-[0207], [0230]).
Regarding claim 32, Ross et al. ‘390 teaches wherein the measuring of the heart rate includes measuring a blood flow rate of the user ([0143]; One of ordinary skill would understand that measuring heart rate would be measuring blood flow rate.).
Regarding claim 33, Ross et al. ‘390 teaches wherein the oxygen saturation sensor comprises a pulse oximetry sensor ([0179]).
Regarding claim 34, Ross et al. ‘390 teaches calibrating the respiratory-system mathematical model of the user with the gas exchange analyzer during a calibration phase ([0136], [0210]).
Regarding claim 36, Ross et al. ‘390 teaches obtaining oxygen partial pressure in the blood of the user based on the oxygen saturation ([0123]; “…oxygen partial pressure (determined using a fluorescent oxygen sensor)…”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. ‘390 in view of Munoz et al. ‘555 (US Pub No. 2017/0168555).
Regarding claim 22, Ross et al. ‘390 teaches wherein the at least one environmental sensor includes a wearable environmental sensor.
Munoz et al. ‘555 teaches a physical activity sensor that comprises a pressure sensor for detecting ambient pressure and a temperature sensor for determining ambient and/or device’s internal temperature. Other physical activity sensors may be available as well, such as an ambient light sensor, a humidity sensor, and/or an electric field sensor. These additional sensors may be, as said earlier, worn by the user or integrated into an exercise device, such as on a treadmill or on a bicycle ([0067]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the worn ambient sensors of Munoz et al. ‘555 for the environmental sensors on the cycle of Ross et al. ‘390 as Munoz et al. ‘555 teaches that the environmental sensors, either worn on the user or integrated onto an exercise device, would perform the same, as simple substitution of one known element for another would obtain predictable results.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. ‘390 in view of Tsow et al. ‘795 (US Pub No. 2015/0369795).
Regarding claim 28, Ross et al. ‘390 teaches all of the elements of the current invention as mentioned above except for wherein the controller is configured to provide an optimal breathing strategy of the user during the use phase.
Tsow et al. ‘795 teaches in the event that normal breathing pattern is not detected, the user is instructed to breath normally to accommodate for possible changes of the user’s breathing pattern and correct errors in the pre-determined breathing pattern ([0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Ross et al. ‘390 to include being configured to provide an optimal breathing strategy of the user during the use phase as Tsow et al. ‘795 teaches that this will aid in accommodating for possible changes of the user’s breathing pattern and correcting errors.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Ross et al. ‘390 in view of Maloney Jr. et al. ‘370 (US Patent No. 5,830,370) further in view of Chen et al. ‘663 (US Pub No. 2010/0298663).
Regarding claim 35, Ross et al. ‘390 teaches all of the elements of the current invention as mentioned above except for wherein the respiratory-system mathematical model is based on a lung diffusion coefficient, lung membrane thickness, and lung area of the user.
Maloney Jr. et al. ‘370 teaches Fick’s fundamental law of diffusion is first set out as follows:
dQ = -kS(yc/yx)dt
where dQ = incremental volume of gas diffusion in the increment of time, dt; k = coefficient of diffusion which is specific for the particular gas and particular membrane expressed in units of area/unit time; S = area of membrane through which the gas diffuses; and yc/yx = the gradient of concentration of the gas (c) as a function of the thickness of the membrane (x) (Column 9 Lines 38-49). This is particularly useful in blood oxygenators (Abstract) by improving mass transfer in compact diffusion devices (Column 2 Lines 52-56).
Chen et al. ‘663 teaches that a patient’s metabolic rate may be approximated by using the Fick equation ([0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the respiratory-system mathematical model of Ross et al. ‘390 to include being based on a lung diffusion coefficient, lung membrane thickness, and lung area of the user as Maloney Jr. et al. ‘370 teaches that implementing Fick’s fundamental law of diffusion will aid in improving mass transfer in compact diffusion devices and Chen et al. ‘663 teaches that the patient’s metabolic rate may be approximated by using the Fick equation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AURELIE H TU/ Primary Examiner, Art Unit 3791